Drugs

Stakeholders Comment on Patient Preference Guide

Four industry stakeholders are recommending changes to an FDA draft guidance on incorporating voluntary patient preference information over the total product lifecycle. AbbVie says it partners with patients, patient organizations, caregivers, and clinicians to ensure that individual experiences, perspectives, needs, and priorities are part of the clinical development process.

The International Society for Pharmacoepidemiology commends FDA’s continued recognition of the importance of patient preference data and its potential to inform the development and evaluation of medical devices and medicines, and the agency’s effort to improve the science and support medical device and pharmaceutical manufacturers.

In its comment letter, Novartis says it would be helpful to devote a section in the guidance to recommended statistical design and analysis methods. It also calls on FDA to stress more strongly the need for a statistical analysis plan at the pre-analysis stage.

AdvaMed provides specific line-by-line comments, as do the other three stakeholders.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome